LIAISON QuantiFERON TB Gold Plus

FDA Premarket Approval P180047 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of change in the liaison quantiferon-tb gold plus assay protocol reagent dispensation sequence. Based upon the information submitted, the pma supplement is approved.

DeviceLIAISON QuantiFERON TB Gold Plus
Generic NameTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis
ApplicantDiaSorin, Inc.
Date Received2020-06-04
Decision Date2020-07-23
PMAP180047
SupplementS003
Product CodeNCD 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address DiaSorin, Inc. 1951 Northwestern Avenue stillwater, MN 55082-0285

Supplemental Filings

Supplement NumberDateSupplement Type
P180047Original Filing
S004 2020-06-18 Real-time Process
S003 2020-06-04 Real-time Process
S002 2020-02-13 Real-time Process
S001

NIH GUDID Devices

Device IDPMASupp
08056771103572 P180047 000
08056771103275 P180047 000
08056771103268 P180047 000

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